Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Correction, 95620 [2016-31391]
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Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
phase of the regulatory review period,
while 457 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: May 25, 2005. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
May 25, 2005.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): July 28, 2014. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
IMLYGIC (BLA 125518) was initially
submitted on July 28, 2014.
3. The date the application was
approved: October 27, 2015. FDA has
verified the applicant’s claim that BLA
125518 was approved on October 27,
2015.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,826 days, 1,764
days, or 1400 days, respectively, of
patent term extension.
sradovich on DSK3GMQ082PROD with NOTICES
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Dated: December 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31322 Filed 12–27–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31391 Filed 12–27–16; 8:45 am]
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[Docket No. FDA–2010–N–0067]
Pharmaceutical Science and Clinical
Pharmacology Advisory Committee;
Notice of Meeting; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Pharmaceutical Science and
Clinical Pharmacology Advisory
Committee; Notice of Meeting’’ that
appeared in the Federal Register of
November 29, 2016 (81 FR 85978). The
document announced the forthcoming
public advisory committee meeting of
the Pharmaceutical Science and Clinical
Pharmacology Advisory Committee. The
document was published with an error
in the DATES section. This document
corrects that error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ACPS-CP@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
In the Federal Register of Tuesday,
November 29, 2016, in FR Doc. 2016–
28723, the following correction is made:
On page 85978, in the third column,
in the DATES section, the following
sentence is to be inserted after the first
sentence: ‘‘FDA is opening a docket for
public comment on this meeting. The
docket number is FDA–2010–N–0067.
The docket will open for public
comment on December 28, 2016. The
docket will close on April 14, 2017.’’
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Evaluation and Assessment
of HRSA Teaching Health Centers
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, HRSA has
submitted an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than January 27, 2017.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Evaluation and Assessment of HRSA
Teaching Health Centers.
OMB No. 0915–0376—Extension.
Abstract: The Teaching Health Center
Graduate Medical Education (THCGME)
program supports new and the
expansion of existing primary care
residency training programs in
community-based settings. The primary
goals of the THCGME program are to
increase the production of primary care
doctors and dentists who are well
prepared to practice in community
settings, particularly with underserved
populations, and to improve the overall
number and geographic distribution of
primary care providers.
SUMMARY:
E:\FR\FM\28DEN1.SGM
28DEN1
]]>Agencies
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Page 95620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31391]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0067]
Pharmaceutical Science and Clinical Pharmacology Advisory
Committee; Notice of Meeting; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Pharmaceutical Science and Clinical Pharmacology Advisory
Committee; Notice of Meeting'' that appeared in the Federal Register of
November 29, 2016 (81 FR 85978). The document announced the forthcoming
public advisory committee meeting of the Pharmaceutical Science and
Clinical Pharmacology Advisory Committee. The document was published
with an error in the DATES section. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, email: ACPS-CP@fda.hhs.gov, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
SUPPLEMENTARY INFORMATION:
In the Federal Register of Tuesday, November 29, 2016, in FR Doc.
2016-28723, the following correction is made:
On page 85978, in the third column, in the DATES section, the
following sentence is to be inserted after the first sentence: ``FDA is
opening a docket for public comment on this meeting. The docket number
is FDA-2010-N-0067. The docket will open for public comment on December
28, 2016. The docket will close on April 14, 2017.''
Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31391 Filed 12-27-16; 8:45 am]
BILLING CODE 4164-01-P
